NCT06499701 Volume Kinetics of Fluid Resuscitation in Early Sepsis
| NCT ID | NCT06499701 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu |
| Condition | Fluid and Electrolyte Imbalance |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-06-19 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2024-06-19 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The recommended volume resuscitation for patients with early sepsis-induced hypoperfusion is at least 30 ml/kg of crystalloid administered within the first three hours. However, this standardized approach does not account for individual patient variability and lacks personalization. Additionally, the effects of administering 30 ml/kg on intercompartmental fluid shifts between the plasma and interstitial compartments remain unclear. This study aims to describe the volume kinetics of administering 30 ml/kg of Ringer's Lactate in patients with early sepsis-induced hypoperfusion within the first three hours.
Eligibility Criteria
Inclusion Criteria: A diagnosis of sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation: * hypotension requiring norepinephrine to maintain a mean arterial blood pressure (MAP) either predefined by the clinician or at 65 mm Hg or higher and/or * a serum lactate level \>2 mmol/L (18mg/dL) and/or * acute oliguria defined as urine output \<0.5mL/kg/hr and/or * mottled skin and/or * capillary refill time \> 3 seconds. Exclusion Criteria: * Administration of at least 1 L of IV fluid in the last 6 hours prior to screening. All crystalloids, colloids and blood products that the patient has received are counted. * Known pregnancy. * Competing causes of lactic acidosis including: seizures within 3 hours of enrollment, use of linezolid or metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders. * End-stage renal disease that requires chronic dialysis. * Concurrent haemorrhagic or obstructive shock. * Increased risk of fluid intolerance: * Echocardiographic evidence of moderate or severe left ventricular systolic dysfunction. * Echocardiographic evidence of moderate or severe right ventricular systolic dysfunction. * Hypoxemia index \< 200 mmHg or sonographic evidence of bilateral B or C profile. * Abdominal compartment syndrome. * Post-cardiac arrest.
Contact & Investigator
Robert Hahn, Professor
STUDY CHAIR
Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment
Frequently Asked Questions
Who can join the NCT06499701 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fluid and Electrolyte Imbalance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06499701 currently recruiting?
Yes, NCT06499701 is actively recruiting participants. Contact the research team at cosmin13mara@yahoo.com for enrollment information.
Where is the NCT06499701 trial being conducted?
This trial is being conducted at Bucharest, Romania, Bucharest, Romania.
Who is sponsoring the NCT06499701 clinical trial?
NCT06499701 is sponsored by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu. The principal investigator is Robert Hahn, Professor at Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment. The trial plans to enroll 15 participants.